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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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LUTONIX® Drug Coated Balloon - 00801741199226

Lutonix 018 4X100MMX150CM
LUTONIX, INC.
LX1815041004F
In Commercial Distribution

  • 00801741199226 ()

  • Balloon Diameter, 4 millimeter
  • Balloon Length, 100 millimeter
  • Catheter Length, 150 centimeter
LX1815041004F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741199219

Lutonix 018 4X80MMX150CM
LUTONIX, INC.
LX181504804F
In Commercial Distribution

  • 00801741199219 ()

  • Catheter Length, 150 centimeter
  • Balloon Length, 80 millimeter
  • Balloon Diameter, 4 millimeter
LX181504804F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741199202

Lutonix 018 4X60MMX150CM
LUTONIX, INC.
LX181504604F
In Commercial Distribution

  • 00801741199202 ()

  • Balloon Diameter, 4 millimeter
  • Catheter Length, 150 centimeter
  • Balloon Length, 60 millimeter
LX181504604F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741199196

Lutonix 018 4X40MMX150CM
LUTONIX, INC.
LX181504404F
In Commercial Distribution

  • 00801741199196 ()

  • Catheter Length, 150 centimeter
  • Balloon Diameter, 4 millimeter
  • Balloon Length, 40 millimeter
LX181504404F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741187704

Lutonix 035 7X100MMX75CM
LUTONIX, INC.
LX35757100V
In Commercial Distribution

  • 00801741187704 ()

  • Balloon Length, 100 Millimeter
  • Catheter Length, 75 Centimeter
  • Balloon Diameter, 7 Millimeter
LX35757100V

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741187698

Lutonix 035 7X80MMX75CM
LUTONIX, INC.
LX3575780V
In Commercial Distribution

  • 00801741187698 ()

  • Balloon Length, 80 Millimeter
  • Catheter Length, 75 Centimeter
  • Balloon Diameter, 7 Millimeter
LX3575780V

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741187681

Lutonix 035 12X60MMX40CM
LUTONIX, INC.
LX35401260V
In Commercial Distribution

  • 00801741187681 ()

  • Catheter Length, 40 Centimeter
  • Balloon Length, 60 Millimeter
  • Balloon Diameter, 12 Millimeter
LX35401260V

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741187636

Lutonix 035 7X80MMX40CM
LUTONIX, INC.
LX3540780V
In Commercial Distribution

  • 00801741187636 ()

  • Balloon Diameter, 7 Millimeter
  • Balloon Length, 80 Millimeter
  • Catheter Length, 40 Centimeter
LX3540780V

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741184727

Lutonix 018 6X300MMX130CM
LUTONIX, INC.
LX1813063005F
In Commercial Distribution

  • 00801741184727 ()

  • Balloon Length, 300 Millimeter
  • Catheter Length, 130 Centimeter
  • Balloon Diameter, 6 Millimeter
LX1813063005F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741184697

Lutonix 018 6X300MMX100CM
LUTONIX, INC.
LX1810063005F
In Commercial Distribution

  • 00801741184697 ()

  • Balloon Length, 300 Millimeter
  • Catheter Length, 100 Centimeter
  • Balloon Diameter, 6 Millimeter
LX1810063005F

  • Peripheral angioplasty balloon catheter, drug-coated
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